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SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to restricted prescription (C)

  • Active Ingredient(s):

    Edotreotide

    *Additional information is available within the SPC or upon request to the company

Updated on 03 October 2023

File name

SomaKit TOC_REG PIL_PF23-0150_28.09.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 February 2023

File name

SomaKit TOC_REG PIL_PF23-0043_13.02.2023_clean_IPHA.pdf

Reasons for updating

  • Change to MA holder contact details

Updated on 22 February 2023

File name

SomaKit TOC_REG SPC_PF23-0043_13.02.2023_clean_IPHA.pdf

Reasons for updating

  • Change to MA holder contact details

Legal category:Product subject to restricted prescription (C)

Updated on 27 September 2022

File name

SomaKit TOC_REG PIL_PF22-0136_19.09.2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 27 September 2022

File name

SomaKit TOC_REG SPC_PF22-0136_19.09.2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

Updated on 23 November 2021

File name

SomaKit_REG SPC_PF21-0244_12.11.2021_clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Removal of Black Inverted Triangle
  • Other

Legal category:Product subject to restricted prescription (C)

Updated on 23 November 2021

File name

SomaKit_REG PIL_PF21-0244_12.11.2021_clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to MA holder contact details
  • Removal of Black Inverted Triangle

Updated on 19 October 2021

File name

SomaKit_REG SPC_PF21-0245_16.09.2021_clean.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Updated on 19 October 2021

File name

SomaKit_REG PIL_PF21-0245_16.09.2021_clean_TBI 16.03.2022.pdf

Reasons for updating

  • New PIL for new product